Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-25 @ 5:10 AM
NCT ID:
NCT06697327
Eligibility Criteria:
Inclusion Criteria:(All of the following criteria must be met.)
Patients with newly diagnosed AML based on FAB classification and flow cytometry standards who are eligible for intensive chemotherapy:
* Age between 18 and 59 years;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3;
* Expected survival time of ≥3 months;
* None of the following severe cardiac, pulmonary, hepatic, or renal conditions:
* History of heart disease requiring treatment for congestive heart failure, or an ejection fraction ≤50%, or chronic stable angina;
* Pulmonary diffusing capacity of carbon monoxide (DLCO) ≤65%, or forced expiratory volume in 1 second (FEV1) ≤65%;
* Moderate liver impairment with total bilirubin \>1.5 to ≤3.0 × the upper limit of normal (ULN);
* Creatinine clearance ≥30 mL/min to \<45 mL/min;
* Has not received radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 4 weeks prior to enrollment;
* Has other comorbidities that, in the physician's judgment, make intensive chemotherapy unsuitable;
* Is capable of understanding and willing to sign the informed consent form for this study.
Exclusion Criteria:(Any of the following criteria will exclude the patient from participation)
* Presence of other malignancies;
* Prior treatment with venetoclax or azacitidine;
* History of angioplasty or stent placement within 12 months prior to signing the informed consent, or a history of myocardial infarction, unstable angina, or other clinically significant heart disease;
* Clinically uncontrolled active infection (including bacterial, fungal, or viral infections);
* Pregnant or breastfeeding women;
* Participation in any other clinical trial within 3 months prior to signing the informed consent;
* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT06697327
Study Brief:
Protocol Section:
NCT06697327